Overview

This trial is active, not recruiting.

Condition sensorineural hearing loss (disorder)
Treatment measurment
Sponsor Bnai Zion Medical Center
Start date January 2014
End date June 2015
Trial size 100 participants
Trial identifier NCT02093806, 0140-13-BNZ

Summary

The purpose of this study is to measure the size of the round window niche and its relation to the mastoid segment of the facial nerve and the mastoid cortex, using high resolution computerized tomography of the temporal bone, in order to assess preoperatively what is the extent of obstruction of the round window membrane and whether there is a surgical possibility of round window approach in the insertion of electrode array into the cochlea

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
Arm
measurment

Primary Outcomes

Measure
the size of round window niche and its relation to the cochlea
time frame: january-june 2014 (six months)

Secondary Outcomes

Measure
sizes of working channel from the mastoid cortex into the round window membrane and its relation to the mastoid sagment of the facial nerve
time frame: january-june 2014 (six months)

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - age 20 years old or older - high resolution computerized tomography of the temporal bone (slices ≤1mm) before the surgery - on the measured slices both the round window niche and the posterior wall of the external ear canal are seen Exclusion Criteria: - inner, middle or external ear malformation - temporal bone malformation - status post cochlear implant - status post temporal bone trauma - slices were the round window niche and the posterior wall of the external ear canal are not seen on the same slice

Additional Information

Official title Clinical Applications of Round Window High Resolution Computerised Tomography Anatomy in Cochlear Implant Surgery
Principal investigator Michal Luntz, Prof.
Description The assessment of the anatomy of the round window will be executed using the stractured measuring software used for imaging of the Bnai Zion medical center (CARESTREAM PACS Ver. 11.0, CARSTREAM HEALTH INC.) in IAC window (centered at 700 with a total width of 4000) in the available zoom by the software (usually 400-800%). Measuring the length (mm) and angle will be executed by the software's structured rulers. Measuring protocol: 1. Measured scans: one taken in an orbito-meatal plane 2. Chosen slices: where both the round window niche and the external ear canal are seen on the same slice 3. Distances measured: 1. Distance 1: between the anterior edge of the round window niche and the cortex of the mastoid, with a minimal distance of 0.5mm to the posterior wall of the external ear canal 2. Distance 2: between the posterior edge of the round window niche and the cortex of the mastoid, with a minimal distance of 0.3mm to the anterior edge of the mastoid segment of the facial nerve. 3. Distance 3: the size of the round window niche (from its anterior to posterior edges) 4. Distance 4: between the anterior (most medial) edge of the round window membrane to a point at least 0.3mm anterior to the mastoid segment of the facial nerve. 5. Distance 5: between the posterior (most lateral) edge of the round window membrane to a point at least 0.3mm anterior to the mastoid segment of the facial nerve 6. Distance 6: size of round window membrane (anterior/medial to posterior/lateral) 7. Distance 7: between the lateral edges of distance 1 and 2 marking the cortical size of the "working channel" created between the lines (from the cortex to the round window). 4. Angles measured: 1. Between distance 1 and 7 - marking the angle of the "working channel" relatively to the cortex 2. Between distance 1, passing in the middle of distance 3 to the middle of distance 6 - marking the angle of possible insertion from the working channel into the cochlea
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Bnai Zion Medical Center.